|
Device |
ureteroscope and accessories, flexible/rigid |
Regulation Description |
Endoscope and accessories. |
Definition |
To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). |
Product Code | FGB |
Regulation Number |
876.1500
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AMBU A/S |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AURIS HEALTH INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BOSTON SCIENTIFIC CORPORATION - |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CENTERPOINT SYSTEMS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DYNE MEDICAL GROUP INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELMED ELEKTRONIK VE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GYRUS ACMI, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUGER MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HUNAN ENDOSO LIFE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD, |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
KARL STORZ ENDOSCOPY AMERICA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KARL STORZ ENDOVISION, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KARL STORZ SE & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MACROLUX MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS WINTER & IBE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OTU MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN BESDATA TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STERIS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
1. K211347 Uretero1 Ureteroscope System
|
2. K223466 Uretero1 Single-Use Digital Flexible Ureteroscope ...
|
3. K231878 Uretero1 Single-Use Digital Flexible Ureteroscope ...
|
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|